This report was first published by Endpoints News. To see the original version, click here
The FDA accused ChemoCentryx of manipulating the results of a pivotal clinical trial used to approve the drug Tavneos, escalating the agency’s effort to pull the treatment from the market.
“New information shows that the applicant’s unblinded study personnel manipulated endpoint results for the Phase 3 study,” the FDA said in a letter outlining its concerns and demanding that Amgen remove the product. That language appears to be far more severe than what has been public so far.
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